Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

CSL Behring89 enrolled

Overview

The purpose of this study is to demonstrate the effect of IgPro10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IgPro10 are studied. A part of the patients are participating in a pharmacokinetic substudy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency

Interventions

Immunoglobulins Intravenous (Human)DRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 70 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Patients with primary immunodeficiency * Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months Key Exclusion Criteria: * Newly diagnosed PID * Allergic reactions to immunoglobulins or other blood products * Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs * Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine * History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension

Outcomes

Primary Outcomes

Annualized rate of acute serious bacterial infections

Secondary Outcomes

Number of infections

Number of days out of work / school due to underlying PID

Adverse events temporally associated with study drug infusion

Trough levels of total IgG serum concentrations

Data from ClinicalTrials.gov

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